BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES

    MDR report key: 16108918 · Received January 5, 2023

    Report

    Report Number
    1917413-2023-00002
    Event Type
    Malfunction
    Date Received
    January 5, 2023
    Date of Event
    April 26, 2022
    Report Date
    January 19, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903630832
    PMA / PMN Number
    K013971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: LOT: 2109028, 1195658, 1137333, 1195659, 1195660, 1259185, 1319176, 1319177, 1319180, 1350275, 1350276, 2018814, 2018816, 2056970, 2080608, 2080614, UNKNOWN BD RECEIVED 10 SAMPLES OF LOT 2109028 FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. NO OTHER SAMPLES FOR LOTS 1195658, 1137333, 1195659, 1195660, 1259185, 1319176, 1319177, 1319180, 1350275, 1350276, 2018814, 2018816, 2056970, 2080608, 2080614, UNKNOWN OR NO PHOTOS WERE PROVIDED IN SUPPORT OF THIS COMPLAINT. THE 10 SAMPLE TUBES FROM LOT 2109028 WERE DRAW TESTED. ALL TUBES WERE WITHIN SPECIFICATION LIMITS. ADDITIONALLY, 10 RETENTION SAMPLES OF LOT 2109028 FROM THE BD INVENTORY WERE FUNCTIONALLY TESTED AND ALL TUBES WERE WITHIN SPECIFICATION LIMITS. ALL OTHER LOTS AFFECTED WERE EXPIRED AT TIME OF INVESTIGATION; THEREFORE, NO RETENTION TESTING WAS COMPLETED ON THE EXPIRED LOT NUMBERS. BD WAS UNABLE TO CONFIRM AND/OR DUPLICATE THE CUSTOMER¿S INDICATED FAILURE MODE BECAUSE THE DEFECT WAS NOT OBSERVED IN THE SAMPLE AND RETENTION TESTING. THE DEVICE HISTORY RECORDS FOR ALL LOTS AFFECTED WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. H3 OTHER TEXT : SEE H.10

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THIS EVENT OCCURRED 4 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WE ARE EXPERIENCING LOW FILL VOLUME." THERE WERE NO ERRONEOUS RESULTS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THIS EVENT OCCURRED 4 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WE ARE EXPERIENCING LOW FILL VOLUME." THERE WERE NO ERRONEOUS RESULTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192413 BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 363083 1195659 50382903630832

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown